Topical Anaesthesia in Cutaneous Head and Neck Surgery

NCT06274905 | Completed

• 1 other identifier: 160123
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess if EMLA or ethyl chloride spray are effective in reducing the pain associated with local anaesthetic administration in cutaneous surgery of the head and neck compared to a placebo and control group through a randomized control trial study design.

Conditions

Pain, Acute; Head and Neck Cancer; Cutaneous Tumor

Outcome Measures

Primary Outcomes (1)

• Pain score

  The primary outcome measure is patient reported pain on a numeric rating scale (NRS)(1; no pain, 10; worst pain imaginable) recorded after LA administration

  The pain score is measured essentially immediately after administration of the local anaesthetic (within 20 seconds of administration).

Secondary Outcomes (1)

• Patient satisfaction

  The overall patient satisfaction score is measured essentially immediately after the operation had concluded (within 20 seconds of completion).

Study Arms (4)

EMLA cream

EXPERIMENTAL

EMLA cream 5% 25g lidocaine, 25g prilocaine; Astra Zeneca. Topically applied followed by Tegaderm dressing to cover. Length of duration monitored and recorded as part of study

Drug: EMLA

EMLA placebo

PLACEBO COMPARATOR

Aqueous cream ((Ultrapure Laboratories®️, Mayo, Ireland) applied topically followed by covering with Tegaderm dressing. Length of duration monitored and recorded as part of study

Drug: Aqueous cream BP

Ethyl chloride spray

EXPERIMENTAL

Ethyl chloride spray (Cryogesic®, Fannin Ltd, Dublin, Ireland). Applied topically to surgical site prior to LA injection. Spray at distance of 5-10cm for 4-8 seconds until skin slightly blanched and the fluid allowed to evaporate.

Drug: Ethyl chloride

Control group

NO INTERVENTION

No intervention administered

Interventions

EMLA DRUG

EMLA cream

EMLA cream

Ethyl chloride DRUG

Ethyl chloride

Ethyl chloride spray

Aqueous cream BP DRUG

Aqueous cream

EMLA placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged at least 18 years
• Receiving surgery to cutaneous tissues of the head and neck
• Procedure performed under local anaesthetic

You may not qualify if:

• Paediatric patients
• Surgery performed under general anaesthetic
• Mucosal operative site (e.g. oral cavity)
• Significant cognitive impairment (e.g. severe dementia)
• Known sensitivity/allergy to EMLA
• History of a pain disorder (e.g. complex regional pain syndrome).

Sponsors & Collaborators

• University Hospital Waterford: lead

Study Sites (1)

University Hospital Waterford

Waterford, X91 ER8E, Ireland

Location

MeSH Terms

Conditions

Acute Pain; Head and Neck Neoplasms; Skin Neoplasms

Interventions

Ethyl Chloride

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Hydrocarbons, Chlorinated; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single blinding (for participants) only for patients receiving EMLA or EMLA placebo.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2024
• First Posted: February 23, 2024
• Study Start: February 20, 2023
• Primary Completion: July 7, 2023
• Study Completion: July 7, 2023
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)